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Okay, so I guess the honor of posting the first topic of this subject of the new forums falls to me!

I'll start if off with a re-post of status of the research regarding the promising Tat Oyi vaccine. I have been lucky to have been corresponding with Dr. Erwann Loret, who is in charge of the research. I've pasted some of the details of the publication he put out after his study of the effects of the Tat Oyi vaccine on SIV challeneged macaques. The summary of the status, however, was that every single macaque who received the Tat Oyi vaccine had an antibody response to Tat. One macaque was even challenged twice, yet after 6 months no viral reservoir was found. This is very important news indeed. Phase one trials are being prepared, to begin sometime in 2007. So far they will be conducted in Maresille. I'll post more on this in later posts. Read on!

Three adjuvants authorized for human use trigger an immune response with Tat Oyi similar to what was observed with the complete Freund adjuvant in a former study [22]. No local or systemic toxicity or adverse effects were observed in rabbits and macaques with vaccine doses superior to those planed for clinical trials. Furthermore, the synthetic protein Tat Oyi is pharmacologically stable in solution for at least a period of one month, which is a requirement for mass vaccination (data not shown).

Although a low viremia was not achieved for all macaques, reservoir cells were no longer detectable 56 days after a heterologuous challenge. Taken together, these results suggest that a Tat Oyi synthetic protein could be an excellent component of a vaccine targeting HIV-1 and could provide an appropriate treatment against HIV- 1 in both developing and industrial countries. On a fundamental point of view, the decreased level of CD8 cells in the control macaques suggests an important role of extra cellular Tat in the immunodeficiency induced by the HIV-1. We hope to be able to confirm in phase I/II clinical trial with seropositive patients that a therapeutical effect can be obtained from the Tat Oyi vaccination.

This therapeutic effect might result, firstly, in a reduced viremia and stable CD4 cells level following an interruption of the antiretroviral treatment. We believe this vaccine will not prevent sero negative people from HIV infection, however it could avoid the collapse of the cellular immunity, and therefore a therapeutic effect could be expected with the eradication of the virus titres and viral reservoir as is observed with HEPS patients. This vaccine could be also the only affordable therapy for millions of seropositive patients that have no access to antiretroviral treatment.

« Last Edit: June 02, 2006, 11:16:55 PM by J220 »

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

I finally found out what is exactly going on in Madrid (clinica sandoval) with the testing of a vaccine. They are just recruiting volunteers to test a vaccine (any vaccine anytime in the future). But nothing else...They believe a vaccine is decades away.

Too bad, I was looking forward to seeing the Ensoli trials being conducted in Spain as well (besides Italy and Africa).

As far as what you were told about the expected timeline for a vaccine, you know where I stand on that! An outright cure/ eradication might take longer, but we are just around the corner regarding therapeutic vaccines that will make haart medications a thing of the past.

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

What exactly is going on with the Ensoli trials? Has it officially entered Phase II yet?

And what about Remune? A press release last year indicated that it was about to (re-)enter Phase III as a medication-sparing therapeutic vaccine (either as a first treatment option or as something that could be taken after meds are discontinued):

A) the last official release from her team was when they announced they were cutting the phase one trial short because of "surpassed expectations".

B) All patients had both cellular and immune responses (can't remember the number, but I believe it was something like 80% and 100 % of subjects, respectively.)

C) They said they were moving forward with phase two, wider-scale tests in both Italy and Africa. Last I heard- albeit through third parties- was that phase two would start sometime in September.

All indications are that anti-Tat therapy is effective. Below I copy a little information on Tat itself, and why this is now a prime target of HIV therapy. This comes from one of the many recent publications that have identified the crucial role of Tat.

____________________________________________

What is Tat?

Tat is an 86- to 102-amino-acid transcriptional activator that is encoded by two exons and is highly conserved among HIV isolates. It is produced early during the virus life cycle and is essential for efficient virus replication (4, 9). Several in vitro studies have demonstrated that Tat is secreted from virus-infected cells and exerts its biological effects on neighboring cells by (i) inhibiting T-cell proliferation, (ii) inducing apoptotic cell death, and (iii) increasing permissiveness for infection by both macrophage-tropic and T-cell-tropic HIV isolates as a result of enhanced expression of CXCR4 and CCR5 on susceptible cells. Thus, Tat appears to be involved in both host immune suppression and viral dissemination.

Why use Tat as a vaccine?

The rationale for using Tat as a vaccine target for HIV is supported by the following. First, Tat induces both humoral and cellular immune responses in humans (16, 17, 28). Second, anti-Tat antibodies protect against the increased permissiveness for HIV infection and the inhibitory effects on T-cell proliferation (12, 31, 36) and thus may control disease progression. Third, in HIV-1-infected individuals, anti-Tat antibodies correlate inversely with progression to AIDS (25, 36). In addition, in a recent study of 57 HIV-1-infected subjects, CD8+ T-cell responses against Tat were evident in 19% of these individuals, indicating that Tat is frequently targeted by HIV-1-specific cytotoxic T lymphocytes (CTL) (1). Furthermore, in nonhuman primates, there appears to be selective pressure on Tat CTL epitopes during the acute phase of SIV infection, suggesting that CTL against Tat may play an important role in disease control (2).

_____________________________

Anyway, I have links to many publications regading Tat research, both in vitro and vivo. The conclusions of all research so far are universal, in that targeting Tat results in inhibition of replication and an increase in immune system response. I cannot say much about Ensoli's trial, other than what is publicaly known already, because I have not been able to communicate with anyone associated with that research. I have however, as I stated earlier in the thread, had the good fortune to link up with Dr. Loret. In short, and regarding his testing of the Tat Oyi vaccine in macaques, he states:

The resistance of this macaque [number 966] to SHIV was so impressive that it was challenged twice with another SHIV strain. This second SHIV challenge made possible to see the retroconversion and to reproduce experimentally the serological phenotype observed in Gabon and reported in 1989 by Huet et al.

For those that don't know, the Tat Oyi variant used for Loret's vaccine was identified in a group of individuals in Gabon who retroconverted (sp?). He wrote:

The base of our approach is to have selected the Tat Oyi variant identified in seropositif patients who became seronegative. This cohort was identified in 1986 in Gabon and they were cleared of infection in 1996

So, these are the reasons why anti-Tat therapy is so promising. Indeed, Ensoli's vaccine certainly seems to be doing very well. Ensoli's research began a bit earlier, with some of the first papers which identified Tat antibodies as an important marker for disease progression (i.e. most patients with significant Tat antibodies had a slower, or nonexistent, disease progression).

Loret's phase one trial is set to begin in 2007. If human subjects have a response anywhere close to what was seen in the SHIV models, we should be seeing extremely significant results, perhaps even better that Ensoli's, due to the specificity of the Tat Oyi variant (identified in the patients who became seronegative). In any case, I think anti-Tat is the next big thing, and could very well mean, at the very least, a dramatic shift from present treatment methods (haart), in particular when you consider that anti-Tat therapy is not affected by any resistance issues. And all this with no side effects...not bad. J.

« Last Edit: June 03, 2006, 09:31:36 PM by J220 »

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

Thanks a lot for the info on anti-TAT, J. I'd also heard the news that the Ensoli vaccine had surpassed phase I expectations and is entering phase II ahead of schedule. I just wasn't sure whether the phase II trial had begun yet.

No resistance or side effects would certainly be great advantages for an anti-TAT vaccine. We might also add 1) freedom from the issues (practical, emotional, and psychological) associated with round-the-clock pill therapy and, more importantly, 2) a lower cost, which would mean a real treatment option for the 95% of the world's HIV+ individuals who can't afford expensive HAART medications.

It wouldn't be wise to count any chickens before they hatch, but I am watching the anti-TAT scene with a lot of interest.

Another thing I remembered regarding Ensoli's trial, and this is something I read- although I cannot remember where. I think that for the phase two trials they are going to administer the vaccine to all volunteers, and not exclude a placebo group. This can only mean (to me) a confirmation that the vaccine is working, and they want to have as much data as possible to establish its efficacy accross the board.

And you are so correct, in terms of this type of vaccine being affordable/ accessible to everyone. As Loret's publication concluded:

1) The synthetic protein Tat Oyi is pharmacologically stable in solution for at least a period of one month, which is a requirement for mass vaccination....This vaccine could be also the only affordable therapy for millions of seropositive patients that have no access to antiretroviral treatment. J.

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

...it wouldn't be wise to count any chickens before they hatch, but I am watching the anti-TAT scene with a lot of interest.

Good advice, always. And I also am watching this with great intersest. I don't think people in general are aware of the significance of anti-Tat vaccines: without Tat there is no hiv replication, and, in the case of the macaques vaccinated with the Tat Oyi vaccine, no viral reservoir.

I'll add something else that Dr. Loret wrote to me:

The vaccine has the great advantage...to cure a patient with two or three injections instead to be dependent of a drug that you have to take every day.

This, of course, is said with the universal caveat of 'if it works', but judging from the preclinical in vitro tests, the tests in animal models (there have been at least two that I know of), and Ensoli's phase one results, there is every indication that it does.

« Last Edit: June 04, 2006, 08:08:06 PM by J220 »

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

It is interesting (and could be interpreted as encouraging) that the upcoming Ensoli trials will exclude a placebo group. Where did you get this information? I'm just curious because I haven't been able to find out much about the vaccine other than the press releases and what my very limited Italian has enabled me to gather from Lilachat.

Getting rid of viral reservoirs would be a great advantage, but I think that the first target should be getting people off HAART. HAART has worked real wonders, but it's over a decade old, expensive, sometimes really inconvenient, and laden with side effects. Most of us would readily admit that HAART is infinitely better than pre-HAART, but we need a better solution, and if anti-TAT is it, then more power to it.

And the sooner the better. The Ensoli vaccine has been in development for longer than the TAT Oyi, so I think that priority efforts should focus on measuring the efficacy of the Ensoli vaccine and, if everything is all right, getting it to the people.

I can't remember where I read about their (Ensoli's) plan to administer the vaccine to all subjects in the trial. I do know that it wasn't a forum, I believe it was an online article (journalistic). I'll try to see if I can find it again.

If you read lilachat.it regularly, you probably know that there was a person there, "Xavier", that participated in the trial. She said that the results so far for her and others, were "optimal", but that couldn't say more than that because apparently one of the conditions of the trial was that she would not give any public information on results.

She even said that if those in charge of running the trial found out that any volunteer was leaking information, they would exclude that person from the phase two. Talk about holding their cards close to their chest! Personally, I can't but interpret that as a good. And there's no question, a priority is to make haart obsolete, and it looks that a tat toxoid will do the trick.

A piece of trivia, not sure if I mentioned this before, but Ensoli was able to secure funding for her research from (among other sources) the IAVI. Dr. Loret also tried to secure funding from IAVI for his phase one trial, but since they had commited to Ensoli's project already they passed on Loret's. Dr; Loret also speculates that the IAVI probably felt that funding one tat vaccine was enough.

Oh another thing, that illustrates the structured and generally inflexible nature of the research business. If you read the publication regarding Dr. Loret's study- the link is an earlier post here- you'll see that macaque number 966 was challenged twice. The decision to challenge (meaning to attempt to infect) that particular macaque twice was due to its astounding antibody response and the subsequent undetectability of the viral reservoir.

It was an opportunity to prove even further the efficacy of the Tat Oyi vacicne, and it did prove it. However, because the second challenge was not planned in the test protocol, when the results publication was submitted to Nature magazine it was rejected!

In any case, the research was ultimately published of course, and the results peer-reviewed. Ironically, Dr. Ensoli is considered somewhat of a maverick, to the point that she had a falling out with her mentor, Dr. Gringeri, I think, who was also pursuing his own anti-Tat vaccine. His results so far have been closely guarded, athough initial tests appear to have been less dramatic that Ensoli's. To make the divide even bigger between teacher and pupil, Ensoli is now the head of the health ministry in Italy!

So as you can see, there is apparently the makings of a bona-fide soap opera regarding anti-tat. Again, the fact that this is all centered upon a tat vaccine is encouraging. After all, who would compete so hard over something that had no potential?

I know I go on and on about Dr. Loret's research, but that is a function of the fact that his results which are very recent (10/05) are publically available and also because he has been kind enough to anwer all my questions. If only Dr. Ensoli would open up to the public as well...

« Last Edit: June 05, 2006, 03:34:49 PM by J220 »

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

It was an opportunity to prove even further the efficacy of the Tat Oyi vacicne, and it did prove it. However, because the second challenge was not planned in the test protocol, when the results publication was submitted to Nature magazine it was rejected!

Uggh. Things like this frustrate me because they seem so inane. Given the extent of the HIV pandemic, it would seem ludicrous (to say the least) to reject such results on these grounds.

I am aware of "Xavier's" participation in the Ensoli trials and Goldrake's information on the vaccine. I understand the need to keep data under wraps, but it can be maddening considering how many novel approaches to therapy have emerged, only to vanish without a trace over the course of clinical studies. So I hope that some information about the Ensoli trials is periodically released to the public.

Speaking of vanishing without a trace, Gringeri's vaccine supposedly entered Phase IV (!), and nothing more has been heard. It's difficult to believe that a vaccine candidate would have progressed so far without being available to some patients or at least receiving some media attention.

I understand that Ensoli is somewhat of a hero in Italy (at least in some circles), and it's encouraging that her work is taken so seriously that she has been appointed to head the Ministry of Health. This appointment should logically ensure that her own research interests (anti-TAT) won't be neglected. Let's hope that this soap opera emerging between Ensoli, Gringeri, etc. won't interfere with what's truly important: effective vaccine development.

Wow, Gringeri's trials are in phase 4? I had no idea. I knew he was already working with actual people but not that he was that far ahead. And yet no solid information comes out, either with his or Ensoli's. It's like a black hole, only an Italian one. I can only speculate that because they are competing so closely to each other they are being tight-lipped...no need to give the other any advantage? If only it's that, and not that they've hit a snag- although Gringeri's being in phase four would seem to preclude that. So...we keep watching!

p.s. I think the competition can only be agood thing....hurry and finish your vaccine before the other guys does!

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

However, I can't find any other information about Gringeri's trials! I don't think that the secrecy necessarily points to a snag. If we look at Ensoli's research, we'll notice that there have been relatively long gaps between positive announcements so let's keep those fingers crossed. Personally, I'd love to see very frequent updates on these studies, but it obviously takes time to observe trial participants and collect data.

This could be like what happened before the first PI came out in '95. There was little, if any info made available to the public, and then, all of a sudden, HAART was being prescribed to patients.

You're right, though-the competition could give these researchers an added motivation to to really race for the vaccine.

I still wonder how they plan to measure viral load in these latent cells, since they could be anywhere in the body and its fluids. Supposedly even if there's one tiny bit of virus in the body, then the infection can spring back, so viral eradication would have to be nothing less than 100%.

Then again, they've managed to determine when syphilis (a bacteria that can spread throughout the body) is cleared, so I guess that somehow they could do it with HIV.

J220:I also remember the article stating the Ensoli trials would be open to a wide variety of patients, treatment naive and treatment experiences with tcell counts below 200. The Gallo TAT inhibitor trials at Baltimore, MD (I believe associated w/U of MD) took only subjects w/TCell counts over 250. Another TAT inhibitor trial at Duke University, that was slated to be recruiting sometime this year, took only subjects with TCell counts over 350. I haven't heard anything about either of these except Gallo was saying his vaccine should be just as good as Ensoli's, with less risk based on the way the vaccine is manufactured.

It makes me believe Ensoli has a lot of faith in the ability of her vaccine to suppress HIV even in patients with compromised immune systems.

Since Tat is indispensable for the virus to replicate it follows that anti-tat therapy would improve most patients' condition. I am sure that when information is finally released we're going to hear very good things.

And yes, I recall that Gallo and Gringeri were critical of Ensoli's choice of anti-Tat, but she obviously claims it is safe enough. Dr. Loret also disagreed with Ensoli, but mainly from the standpoint of effectiveness. He wrote.

We [Loret and his team] both target Tat but I disagree with Barbara [Ensoli] on the point that any Tat protein can trigger an immune response that will neutralyse Tat. At least a third of HIV infected patients have Tat antibodies and it does not help to reduce their viremia or to avoid progression to AIDS. The base of our approach is to have selected the Tat Oyi variant identified in seropositif patients who became seronegative. This cohort was identified in 1986 in Gabon and they were cleared of infection in 1996.

This is one of the reasons why I feel Loret's approach, standing on it own, will work. I am really looking forward to his phase one results.

Having said that, the results so far from Ensoli and Gringeri is vey good. So even if a patient already has ineffective tat antibodies, it seems that giving them the anti-tat shots boosts the antibody activity.

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

Seropositive patients who became seronegative? If this is true, why hasn't the public heard more about this? The generally accepted idea is that, at this point, no adult (other than perhaps that British man last year, and that's being debated) has ever totally cleared the virus and gone from being poz to neg.How would the antibodies to HIV be wiped out along with the virus?

I don't know why this wasn't been talked about more..I have never heard of that cohort either. And I am not clear either on the question of hiv anibodies. Maybe it's a matter of their definition of seronegative? I am not sure. I'll do some research to see what I can find about that group in Gabon.

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

Is their vaccine in phase 4 because the antibody activity only lasts 4 months? Is phase 4 part of an attempt to fix the problem. From the interview, it seems he knows they are onto something but he wont give it away. How I wish the solution is found quickly.

I think the reason the trial is phase 4 is just because that is where it is, in terms of the development, not because the vaccine lasts only four months.

Also, it seems to me that the infromation in that interview is somewhat dated, it may not actually be from Dec 2005 (the article says "published Dec 05). For example, the article states that the vaccine has been tested on anmals, but in fact the vaccine has already been tested on volunteers, that's why it's in phase 4.

In any case a vaccine that only elicits an anti-Tat response for 3-4 months is a momumental step forward, nevertheless. As we've all stated over and over, compared to daily meds, a once-every-three-months shot that protects your immune system, and keeps you asymptomatic is the next best thing to a cure.

It is evident that they are (all researchers working on anti-tat antibodies) are on to something. There are different Tat variants, and this is part of the resone that Gringeri and Ensoli parted ways. Loret, for his part, is confident that his variant is better suited to elicit a permament anti-tat response.

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

why is none of this information coming out in the news even on this site

Well, first of all, the researchers working on this have yet to make a bona-fide press release on their complete findings. Dr. Ensoli went only as far as saying that her phase one exceeded expectations, she gave some numbers regarding cellular and immune response (all excellent) and quickly shut up. Gringeri has been even more tight-lipped, and has released even less information. We do know that he completed phase three and we believe that he is now in phase four, but nothing more has been said. The media, consequently, cannot report on nothing. But we can look forward to a full press release, along with all appropriate fanfare, whenever either of these two do finish their research. Remember, they are directly competing against each other. Although it would be better if they were working together, at least this competing will motivate them to work faster, to see who reaches the goal line first.

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

And the big question, of course, is when any of this, if it's as effective as we're hoping, would/will actually be available to the public.

One would think (and given the urgency of finding something to fight the pandemic in the developing world) that Gringeri's vaccine would have already been available to someone since it's in Phase IV (normally vaccines and medications seem to be released to the public after Phase III). I can certainly respect the "let's just make sure it works" attitude, but when delays turn into many years, it is both frustrating and counterproductive.

Thanks for that info. The main result I get from a search is from that group kurosawa. I've come across them before while doing research, and at this point have no clue if they're quacks out to get people's money or not...it seems well written though. I'll forward this to a couple of the people here who heve medical/ science backgrounds to hear their thoughts. In the meantime I suppose I'll consider adding niacinamide to my daily vitamins.

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

don't you think that if this was such a breakthrough that something more substantial would have leaked out by now? I mean it seems that every time there really is a small step forward in research it is hailed as "the new cure" when actually it may only be a minor step forward. If this is as big a deal as suggested here it seems to me that it would be a pretty hard secret to keep. Can you imagine being in that research study and having your virus essentially disappear and then keeping your mouth shut about it? Sounds hard to believe. I really, really, really, hope I'm wrong.

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"The trouble with the world is that the stupid are cocksure and the intelligent are full of doubt."

Look at it this way... with Big Pharma standing to pull down at least $10Billion by the end of this decade selling HAART, that's a big incentive to block anything that threatens it... at any cost... especially something in the public sector like the Ensoli trial. Also, i don't think prematurely pumping the possibilities of a treatment goes down well within the peer research group. It could mean ending the possibility of ever getting funding for another trial. If phase two is run for 48 weeks.. and it started Fall, 2007, I think we'll hear something by late 2007 or 2008... good or bad. If it's bad... perhaps earlier. If it's really good, they may choose to withhold publishing any preliminary data until the full 48 weeks worth of data can be analyzed.

Not to derail the thread, but while I agree that there are strong incentives for HAART-manufacturing drug companies to prevent a cure from being found, there are equally strong incentives for other companies to make their billions by coming up with cure first. Competition is the name of the game.

There is so much public scrutiny on the world hiv problem that I doubt that a single company or a group of companies can just block research at their whim. At worse they can choose not to use their resources to work on finding a cure, but I doubt they can engage in a world-wide conspiracy to block the search for a cure. There are just too many parties and variables involved for this to happen.

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"Hope is my philosophy Just needs days in which to beLove of Life means hope for meBorn on a New Day" - John David

There is so much public scrutiny on the world hiv problem that I doubt that a single company or a group of companies can just block research at their whim. At worse they can choose not to use their resources to work on finding a cure, but I doubt they can engage in a world-wide conspiracy to block the search for a cure. There are just too many parties and variables involved for this to happen.

I can honestly say that I have hope that if not a cure at least a treatment/therapy that would keep us healthy and alive will be found very soon. I honestly despise those people who comment and say that there will be no cure nor vaccine in the near future. Those people not only are discourging themselves but many people who have been living with HIV for years. I feel strongly that we all must try our best in keeping ourselves clean from recreational drugs/ use vitamins and think good thoughts to stay healthy. I was recently diagnosed with the virus and feel like the world just came down but have picked myself up and keeping my spirit alive to keep my body alive.

This vaccine should be talked about more to keep those in despair and hopeless with some hope.

Clinical trials announced for new AIDS vaccineMarseille Public University Hospitals (AP-HM) announced on 29th January that they are to carry out clinical trials on a new treatment vaccine for AIDS. Following research by Dr. Erwann Loret, the trials are to be held in France and led by Dr. Isabelle Ravaux from the Department of Infectious Diseases at Marseille H˘pital de la Conception (AP-HM). She talked to Doctissimo about the hopes for the Tat Oyi vaccine.

But isn't it better to have a medicine injected every two months, instead of drinking pills every day? Plus, in the presentation of the project, no such fact is stated. Are you sure you're talking about the same thing?